FDA product code KHR: Absorber, Saliva, Paper
KHR is the FDA product code for absorber, saliva, paper. It is a Class I device, regulated under 21 CFR 872.6050 and reviewed by the Dental panel. FDA has cleared 10 510(k) submissions under KHR, from 10 different applicants. The average 510(k) review took 47 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Absorber, Saliva, Paper |
| Device class | Class I |
| Regulation | 21 CFR 872.6050 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KHR clearance
Top KHR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Irt Management Corp. | 1 | 1998-04-21 |
| Physician Industries, Inc. | 1 | 1995-11-08 |
| Remington Medical, Inc. | 1 | 1995-10-02 |
| Dispomed, Inc. | 1 | 1989-05-01 |
| American Orthodontics | 1 | 1989-04-17 |
5 more applicants have KHR clearances. See the full list in Caduvo.
Most recent KHR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K980783 | Irt Management Corp. | SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 | 1998-04-21 | 50 |
| K954068 | Physician Industries, Inc. | GENERAL HYGIENE KIT | 1995-11-08 | 70 |
| K953812 | Remington Medical, Inc. | GAUZE SPONGE | 1995-10-02 | 61 |
| K891054 | Dispomed, Inc. | NON-STERILE GAUZE SPONGE | 1989-05-01 | 63 |
| K891354 | American Orthodontics | ORTHODONTIC COTTON ROLL HOLDERS | 1989-04-17 | 38 |
Recalls for KHR devices
openFDA lists no recalls for product code KHR.
Frequently asked questions
What is FDA product code KHR?
KHR is the FDA product code for absorber, saliva, paper. It is a Class I device, regulated under 21 CFR 872.6050 and reviewed by the Dental panel.
What device class is KHR?
Class I, regulation 21 CFR 872.6050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KHR?
Across 10 cleared submissions the average was 47 days from receipt to decision (median 44).
Which companies have the most KHR clearances?
Irt Management Corp. (1); Physician Industries, Inc. (1); Remington Medical, Inc. (1); Dispomed, Inc. (1); American Orthodontics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KHR
- Run a recall and safety report across every KHR manufacturer
- Watch product code KHR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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